Transvaginal Mesh Devices Under Fire

Transvaginal mesh devices took a hit in two separate legal actions this week.

An Atlantic City jury ordered health products giant, Johnson & Johnson to pay $7.8 million in punitive damages to a former hospice nurse for the pain and suffering she alleged following implantation with a transvaginal mesh device sold by J&J’s Ethicon unit. Earlier this week, noted Philly.com, the woman was awarded $3.35 in compensatory damages. J&J said it intends on appealing the verdicts.

Yesterday, Endo Health Solutions announced that it suffered large losses due, for the most part, over a $640 million write down on the value of its American Medical Systems (AMS) device unit. The unit’s main focus—pelvic health—involves transvaginal vaginal mesh devices, said Philly.com. Endo agreed to acquire AMS and its debt in April 2011.

As we’ve explained, transvaginal mesh implants are medical devices approved to treat pelvic organ prolapse (POP), a condition in which weakened pelvic muscles cause organs to slide out of place. The device is also approved to treat stress urinary incontinence (SUI) and is meant to strengthen pelvic walls. Complication reports, mounting litigation and growing questions over the lack of clinical testing of these devices have raised questions about the devices’ safety and efficacy; many question if transvaginal mesh devices pose more risks than benefits.

Transvaginal mesh has been associated with very serious reactions, and not all are physical. According to the Endo web site, some 34 million women suffer from POP. Meanwhile, J&J faces about 1,800 lawsuits in New Jersey state courts, alone and as of late last year, Endo was facing nearly 3,000 lawsuits. Tens of thousands of lawsuits have been filed against a number of transvaginal mesh device makers, with lawsuits filed in state and federal courts nationwide, noted Philly.com.

Last June, Ethicon announced it would no longer sell four types of transvaginal mesh devices, including the Prolift + M™, TVT Secur, Prolift, and Prosima. And, as we’ve written, the U.S. Food and Drug Administration (FDA) warned that complications associated with transvaginal mesh implants are “not rare.” The agency also stated that no clear evidence exists that transvaginal mesh is better than non-mesh methods for treating POP and SUI and has asked 33 manufacturers to conduct post-market studies evaluating the dangers of transvaginal mesh.

The devices were approved through a fast-track process known as the 510(k). Under the 510(k), a formal review for safety and efficacy is neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, such as metal-on-metal hip implants, the process has drawn increasing criticism.

As we’ve explained, thousands of women were recipients of transvaginal mesh devices, which have come under increased scrutiny since many recipients of these devices began experiencing complications related to their defects. According to an agency Safety Communication issued last summer, the most common reported adverse events related to transvaginal mesh includes: Mesh erosion through the vagina (exposure, extrusion, protrusion); pain; infection; bleeding; pain during sexual intercourse (dyapareunia); organ perforation; and urinary problems.

In fact, regarding the alleged risk of erosion, in which the transvaginal mesh travels through the body’s tissues, the device can become embedded in inappropriate areas, leading to multiple surgeries to remove the device. Sadly, in many cases, erosion is so significant and widespread that the mesh cannot ever be completely removed. Of note, not all of the very serious reactions to which transvaginal mesh has been associated are physical.